Manufacturers of medicinal products have an enormous responsibility to maintain the safety standards prescribed by the U.S. Food and Drug Administration. Hospira, the manufacturers of a range of LifeCare products, recently announced a recall of 11 lots of intravenous solutions after it was detected that one package was punctured, causing a leak of the contents. The recall, of which the FDA is aware, was reported to be voluntary. The range of products that may pose a personal injury threat was distributed in Florida and the rest of the United States.
The intravenous solutions were packed in flexible containers, protected by a plastic over wrap that could expose the products to being punctured by sharp objects. Upon investigation, it was found that the puncture occurred on a conveyor system, and action to eliminate the problem has been taken. Hospira explained that the sterility of the contents of a punctured, leaking container could be compromised by possible contamination. A further danger exists when the contents of a punctured container are administered to a patient as the dosing may be inconsistent, causing a delay in treatment.